Ignite Creation Date:
2024-05-06 @ 7:22 PM
Last Modification Date:
2024-10-26 @ 3:05 PM
Study NCT ID:
NCT05980156
Status:
COMPLETED
Last Update Posted:
2023-08-07
First Post:
2023-07-28
Brief Title:
Comparing Chemoprevention Drugs for School-based Malaria Control
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Clinical Trial to Evaluate Intermittent Screening and Treatment and Intermittent Preventive Treatment of Malaria in Asymptomatic Schoolchildren to Decrease P Falciparum Infection and Transmission Phase 2 Comparing Drug Regimens
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an individually randomized controlled single blind three arm clinical trial of malaria chemoprevention strategies Arm 1 Intermittent preventive treatment with dihydroartemisinin-piperaquine IPT-DP Arm 2 Intermittent preventive treatment with sulfadoxine-pyrimethamine SP plus chloroquine CQ IPT-SPCQ Arm 3 Control - students will receive standard of care no preventive treatment Outcomes include P falciparum infection and parasite density anemia cognitive function and educational testing as well as infection prevalence in young children sleeping students households to assess the impact on transmission
Detailed Description:
Students attending a single primary school in Machinga District Malawi who were enrolled in NCT05244954 were offered enrollment in this follow-on study The intervention will be conducted every 6-weeks during the two school terms which coincide with peak malaria transmission Students in the IPT-DP arm will be treated with with dihydroartemisinin-piperaquine DP females less than 10 years old and all males or chloroquine females 10 years old or older Students in the IPT-SPCQ arm will be treated with sulfadoxine-pyrimethamine plus chloroquine females less than 10 years old and all males or chloroquine alone females 10 years old or older
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None